Bracco is an international Group active in the healthcare sector and a leader in diagnostic imaging. The Group’s main products are contrast agents sold in over 100 countries, both directly and indirectly through branches, joint ventures and license and distribution agreements.

Responsible for the day-to-day operation, maintenance, and improvement of the company’s medical device quality management system (QMS) and quality management of distribution activities, ensuring compliance with Chinese medical device GMP, GSP, ISO 13485, and company QMS requirements. Collaborate with relevant departments on design and development quality support and post-market quality management within assigned responsibilities.

Key Responsibilities

1.     Manage the implementation and maintenance of the QMS in accordance with ISO 13485, applicable regulatory requirements, and company procedures. Oversee document and record control, change control, quality training, and corrective and preventive action (CAPA); monitor process performance and quality objectives; and coordinate and follow-up actions to maintain QMS effectiveness and drive improvement.

• Provide quality support for medical device design and development as needed, helping project teams implement applicable QMS requirements.

3.     Plan and conduct internal audits and supplier audits, ensure that audit findings are investigated, audit findings follow up are implemented within timelines, effectiveness verification and closure.

• Coordinate the assessment and disposition of nonconforming products and quality deviations, ensuring required documentation, approvals, and follow-up actions are completed.

5.     Oversee quality operations across the distribution, including qualification review for suppliers, products, and customers; oversee outsourced storage and transportation providers; and ensure effective product preservation, traceability, and control of distribution records.

6.     Manage complaint handling and adverse event monitoring processes, including intake, evaluation, investigation follow up, reportability assessment, regulatory reporting, and post-market quality data and trends analysis.

7.     Coordinate quality and safety risk review and cross-functional assessments of manufacturing, distribution, and post-market quality risks.

8.     Monitor applicable medical device legislation, regulations, standards, and regulatory guidance. Coordinate changes assessment, implementation of necessary procedural updates, training, and compliance actions.

9.     Other quality management duties assigned by the line manager.

Qualifications

Education and Experience

1.     Bachelor’s degree or higher in medical devices, biomedical engineering, electronic engineering, automation, mechanical engineering, software engineering, medicine, pharmacy, bioengineering, quality management, or a related discipline.

2.     At least 5 years of relevant experience in medical device quality management.

3.     Experience in active medical devices, software quality management, or MAH management is preferred.

Professional Knowledge and Competencies

1.     Strong working knowledge of ISO 13485 and applicable Chinese medical device regulatory requirements, with the ability to translate regulatory and quality system requirements into effective operational controls.

2.     Strong cross-functional leadership, communication, and coordination skills, with a structured approach to root cause analysis, risk-based decision-making, and problem-solving.

3.     ISO 13485 internal auditor or auditor certification is preferred.

Contract type:

Fixed Term

If you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now!

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